Method of restoring settings of an instrument for processing a sample or a reagent and a system for processing a sample or reagent

ABSTRACT

A method for saving and/or restoring settings of an instrument for processing a sample or reagent is disclosed. The instrument comprises a control unit and an operating system. A storage medium is provided to the instrument. The storage medium comprises a script. The script restores data for restoring settings of the instrument. The script is encrypted and/or digitally signed. The method verifies an identity and/or integrity of the script and executes the script upon starting the instrument by the operating system with the storage medium when the identity and/or integrity of the script correspond to an identity and/or integrity of the instrument. The control unit provides an input menu for allowing a user to input a saving and/or restoring command. The instrument saves settings on the storage medium and/or restores settings of the instrument from the storage medium by the restoring data corresponding to the saving and/or restoring command.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to EP 15201311.6, filed Dec. 18, 2015,which is hereby incorporated by reference.

BACKGROUND

The present disclosure generally relates to a method for restoringsettings of an instrument for processing a sample or reagent and asystem comprising an instrument for processing a sample or reagent and astorage medium.

In vitro diagnostic testing has a major effect on clinical decisions byproviding physicians with pivotal information. Particularly, there isgreat emphasis on providing quick and accurate test results in criticalcare settings. In vitro diagnostic testing is usually performed usinginstruments operable to execute one or more processing steps/workflowsteps on one or more biological samples and/or one or more reagents,such as pre-analytical instruments, post-analytical instruments and alsoanalytical instruments.

Analytical instruments/analyzers are configured to obtain a measurementvalue. An analyzer is operable to determine via various chemical,biological, physical, optical or other technical procedures a parametervalue of the sample or a component thereof. An analyzer may be operableto measure the parameter of the sample, or of at least one analyte, andreturn the obtained measurement value. The list of possible analysisresults returned by the analyzer comprises, without limitation,concentrations of the analyte in the sample, a digital (yes or no)result indicating the existence of the analyte in the sample(corresponding to a concentration above the detection level), opticalparameters, DNA or RNA sequences, data obtained from mass spectroscopyof proteins or metabolites and physical or chemical parameters ofvarious types. An analytical instrument may comprise units assistingwith the pipetting, dosing, and mixing of samples and/or reagents. Theanalyzer may comprise a reagent holding unit for holding reagents toperform the assays. Reagents may be arranged for example in the form ofcontainers or cassettes containing individual reagents or group ofreagents, placed in appropriate receptacles or positions within astorage compartment or conveyor. It may comprise a consumable feedingunit. The analyzer may comprise a process and detection system whoseworkflow is optimized for certain types of analysis. Examples of suchanalyzer are clinical chemistry analyzers, coagulation chemistryanalyzers, immunochemistry analyzers, urine analyzers, nucleic acidanalyzers, used to detect the result of chemical or biological reactionsor to monitor the progress of chemical or biological reactions.

In order to ensure proper operation of the instruments and a way torestore setting of the instrument in case of a malfunction/defect,restoring data for restoring settings of the instrument are stored on astorage medium communicatively connected to the instrument. This isusually performed in a so-called backup operation carried out regularly.

Known instruments are configured to receive a storage medium withrestoring data and to recover the instrument settings therefrom. Oneknown solution is that the instrument software is provided with afeature to read the restoring data and restore the instrument settingsaccordingly. However, there are cases when the instrument softwareitself becomes inoperable and/or inaccessible so that even the featureto recover the instrument settings is unavailable and/or unreliable.

In order to address such cases, prior art instruments are known whichare configured to receive a bootable recovery media and boot up theinstrument from said bootable recovery media, the latter comprisingfunctionality to recover the instrument settings.

However, configuring an instrument to accept bootable recovery media andboot therefrom introduces major security vulnerability as it leaves openthe option to boot from malicious bootable media. For example suchmalicious bootable media comprises software code which is designed tocircumvent the data protection and/or the authentication-authorizationmechanisms of the instrument.

Therefore, there is a need for an efficient, flexible and secure backupprocedure of an apparatus for processing a sample or reagent,particularly of an off-line apparatus, such as a medical device, in caseof a system failure.

SUMMARY

According to the present disclosure, a system and method for restoringsettings of an instrument for processing a sample or reagent arepresented. The instrument can comprise a control unit and an operatingsystem. The method can comprise providing a storage medium. The storagemedium can comprise a script and restoring data for restoring settingsof the instrument. The script can be encrypted/digitally signed. Theinstrument can receive the storage medium. The method can furthercomprise verifying an identity and/or integrity of the script, executingthe script upon starting the instrument by the operating system with thestorage medium received by the instrument when the identity and/orintegrity of the script corresponds to an identity of the instrument,providing an input menu by the control unit for allowing a user to inputa saving and/or restoring command, and saving settings of the instrumenton the storage medium and/or restoring settings of the instrument fromthe storage medium by the restoring data corresponding to the savingand/or restoring command.

Accordingly, it is a feature of the embodiments of the presentdisclosure to provide an efficient, flexible and secure backup procedureof an apparatus for processing a sample or reagent, particularly of anoff-line apparatus, such as a medical device, in case of a systemfailure. Other features of the embodiments of the present disclosurewill be apparent in light of the description of the disclosure embodiedherein.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The following detailed description of specific embodiments of thepresent disclosure can be best understood when read in conjunction withthe following drawings, where like structure is indicated with likereference numerals and in which:

FIG. 1 illustrates a perspective view of a system comprising aninstrument for processing a sample or a reagent and a storage mediumaccording to an embodiment of the present disclosure.

FIG. 2 illustrates a flowchart of a method according to the disclosedmethod/system according to an embodiment of the present disclosure.

DETAILED DESCRIPTION

In the following detailed description of the embodiments, reference ismade to the accompanying drawings that form a part hereof, and in whichare shown by way of illustration, and not by way of limitation, specificembodiments in which the disclosure may be practiced. It is to beunderstood that other embodiments may be utilized and that logical,mechanical and electrical changes may be made without departing from thespirit and scope of the present disclosure.

Embodiments of the disclosed method and system aim to provide a safe andreliable way for restoring settings of an instrument.

Disclosed herein are a method for restoring settings of an apparatus forprocessing a sample or reagent and a system comprising an apparatus forprocessing a sample or reagent and a storage medium that provide anefficient, flexible and secure backup procedure of an apparatus forprocessing a sample or reagent, particularly of an off-line apparatus,such as a medical device, in case of a system failure.

As used in the following, the terms “have”, “comprise” or “include” orany arbitrary grammatical variations thereof can be used in anon-exclusive way. Thus, these terms may both refer to a situation inwhich, besides the feature introduced by these terms, no furtherfeatures can be present in the entity described in this context and to asituation in which one or more further features are present. As anexample, the expressions “A has B”, “A comprises B” and “A includes B”may both refer to a situation in which, besides B, no other element ispresent in A (i.e. a situation in which A solely and exclusivelyconsists of B) and to a situation in which, besides B, one or morefurther elements are present in entity A, such as element C, elements Cand D or even further elements.

Further, it shall be noted that the terms “at least one”, “one or more”or similar expressions indicating that a feature or element may bepresent once or more than once typically can be used only once whenintroducing the respective feature or element. In the following, in mostcases, when referring to the respective feature or element, theexpressions “at least one” or “one or more” will not be repeated,non-withstanding the fact that the respective feature or element may bepresent once or more than once.

Further, as used in the following, the terms “particularly”, “moreparticularly”, “specifically”, “more specifically” or similar terms areused in conjunction with additional/alternative features, withoutrestricting alternative possibilities. Thus, features introduced bythese terms are additional/alternative features and are not intended torestrict the scope of the claims in any way. The invention may, as theskilled person will recognize, be performed by using alternativefeatures. Similarly, features introduced by “in an embodiment of theinvention” or similar expressions are intended to beadditional/alternative features, without any restriction regardingalternative embodiments of the invention, without any restrictionsregarding the scope of the invention and without any restrictionregarding the possibility of combining the features introduced in suchway with other additional/alternative or non-additional/alternativefeatures of the invention.

According to the disclosed method/system, a method for restoringsettings of an instrument for processing a sample or reagent isdisclosed. The instrument can comprise a control unit and an operatingsystem. A storage medium can be provided. The storage medium cancomprise a script. The storage medium can also comprise restoring datafor restoring settings of the instrument. The script can be encryptedand/or digitally signed. The instrument can receive the storage medium.An identity and/or integrity of the script can be verified. The scriptcan be executed when the identity and/or integrity of the scriptcorresponds to an identity and/or integrity of the instrument. Thescript can be executed upon starting the instrument by the operatingsystem with the storage medium received by the instrument. An input menucan be provided by the control unit for allowing a user to input asaving and/or restoring command. The settings of the instrument can besaved on the storage medium and/or the settings of the instrument can berestored from the storage medium by the restoring data corresponding tothe saving and/or restoring command. In other words, the settings of theinstrument can be saved on the storage medium and/or the settings of theinstrument can be restored from the storage medium by the restoring datadependent on whether the saving and/or restoring command has been input.

The term “instrument” as used herein can refer to any apparatus, orapparatus component, operable to execute one or more processingsteps/workflow steps on one or more biological samples and/or one ormore reagents. The expression ‘processing steps’ thereby can refer tophysically executed processing steps such as centrifugation,aliquotation, sample analysis and the like. The term ‘instrument’ cancover pre-analytical instruments, post-analytical instruments and alsoanalytical instruments. Thus, the term “instrument” can be usedsynonymous with the term “laboratory instrument.”

The term ‘analyzer’/‘analytical instrument’ as used herein can encompassany apparatus, or apparatus component, configured to obtain ameasurement value. An analyzer can be operable to determine via variouschemical, biological, physical, optical or other technical procedures, aparameter value of the sample, or a component thereof. An analyzer maybe operable to measure the parameter of the sample, or of at least oneanalyte, and return the obtained measurement value. The list of possibleanalysis results returned by the analyzer comprises, without limitation,concentrations of the analyte in the sample, a digital (yes or no)result indicating the existence of the analyte in the sample(corresponding to a concentration above the detection level), opticalparameters, DNA or RNA sequences, data obtained from mass spectroscopyof proteins or metabolites and physical or chemical parameters ofvarious types. An analytical instrument may comprise units assistingwith the pipetting, dosing, and mixing of samples and/or reagents. Theanalyzer may comprise a reagent holding unit for holding reagents toperform the assays. Reagents may be arranged for example in the form ofcontainers or cassettes containing individual reagents or group ofreagents, placed in appropriate receptacles or positions within astorage compartment or conveyor. It may comprise a consumable feedingunit. The analyzer may comprise a process and detection system whoseworkflow is optimized for certain types of analysis. Examples of suchanalyzer are clinical chemistry analyzers, coagulation chemistryanalyzers, immunochemistry analyzers, urine analyzers, nucleic acidanalyzers, used to detect the result of chemical or biological reactionsor to monitor the progress of chemical or biological reactions.

The term “script” as used herein can refer to a program written in ascripting language and that can be written so that the operating systemof the instrument can interpret and execute the instructions of thescript. By contrast, normal programs are typically written in a compiledlanguage and distributed in machine code form. Due to the nature of thescript, modifications can be introduced with very little effort whereasa program based approach can require more significant changes andrecompilation of the software. A script can therefore be a list ofinstructions to be executed.

The term ‘control unit’ as used herein can encompass any physical orvirtual processing device configurable to control a laboratoryinstrument, or system, comprising one or more laboratory instruments ina way that workflow(s) and workflow step(s) can be conducted by thelaboratory instrument/system. The control unit may, for example,instruct the laboratory instrument/system to conduct pre-analytical,post analytical and analytical workflow(s)/workflow step(s). The controlunit may receive information from a data management unit regarding whichsteps need to be performed with a certain sample. In some embodiments,the control unit may be integral with a data management unit, may becomprised by a server computer and/or be part of one laboratoryinstrument or even distributed across multiple instruments of thelaboratory system. The control unit may, for instance, be embodied as aprogrammable logic controller running a computer-readable programprovided with instructions to perform operations.

As mentioned above, the method can include a step of verifying anidentity of the script. This step as used herein can refer to a part ofan authentication process of the script. Authentication can be the actof confirming the truth of an attribute of a single piece of dataclaimed true by an entity. In the disclosed method/system,authentication can involve verifying the validity of identification ofthe script. In other words, the operating system can compare informationconcerning allowable scripts stored on the instrument with informationgiven by the script. If the comparison reveals a match of information,authenticity of the script can be verified, i.e., proofed. In this case,the script can be allowed to be executed.

Alternatively, or in addition, the method can include a step ofverifying an integrity of the script. This step as used herein can referto a part of a process for checking of completeness and/or intactness.With this process, data of the script can be checked which have beenstored on the storage medium beforehand by a comparison based onredundancy such as a checksum added to reference data. Such a checksummay be a digital signature. If this check reveals that the script iscomplete and intact, the script can be allowed to be executed.

The term “settings” as used herein can refer to a configuration of theinstrument, i.e., an arrangement of functional units according to theirnature, number, and chief characteristics. The configuration can affectthe function and performance of the instrument and can include at leastinstructions according to which the instrument acts.

The method can provide flexibility and security as using a scriptinstead of a software based approach can provide platform and devicetype independence. This can mean it can be run on an arm, x86, power pc,and the like without the need to distribute different versions. Further,as the script is encrypted and/or digitally signed, security of the datatransmission can be provided. Particularly, the script may be passwordfree and data transmission can still be secured as the script can onlybe executed if the identity and/or integrity of the script is verified.Furthermore, a backup can be created at any time, even after a failureof the instrument when the normal software doesn't boot, as long as theinstrument hardware is healthy.

In one embodiment, the storage medium may not be bootable. The term“bootable” as used herein can refer to a device that can be booted.Analogously, the term “not bootable” can indicate the avoiding of abootable drive to prevent any operating system to be booted. The term‘boot’ as used herein can refer to an initialization of a computerizedsystem from a switched-off state. Booting typically involves performinga power-on self-test, locating and initializing peripheral device, andthen finding, loading and starting an operating system

A storage medium being not bootable can remove the risk of using amalicious bootable medium to access the data. It can allow a simpleidentification of the authenticity of the stick using signing.

The script may be encrypted by a signature. Thus, a simpleidentification of the authenticity of the storage medium may be providedusing signing.

The method may further comprise decrypting the script when the identityand/or integrity of the script correspond to the identity and/orintegrity of the instrument. Thus, the script cannot be viewed norchanged due to encryption but only after decryption.

Restoring settings of the instrument from the storage medium may includecopying the restoring data from the storage medium to the instrument.Thus, a full data backup or update can be allowed which can beparticularly relevant for debugging purposes wherein an issue could becaused due to unknown data.

Restoring of settings of the instrument from the storage medium mayinclude decrypting the restoring data from the storage medium. Thus, itcan be ensured that the restoring data can be only copied to theinstrument if the identity and/or integrity of the script corresponds tothe identity and/or integrity of the instrument as only in this case therestoring data are decrypted. Thus, security of the restoring data canbe increased.

Saving settings of the instrument may include copying settings data onthe storage medium. Thus, backup data may be generated and the settingsmay be duplicated.

Saving settings of the instrument on the storage medium may includeencrypting settings data on the storage medium. Thus, the settings canbe securely stored.

The settings of the instrument may be stored in a database. Savingsettings may include copying the database on the storage medium. Thus, ageneration of full backup data can be possible contrary to using acompact flash card, wherein only a partial backup data generation can bepossible.

The database may be compressed before being copied on the storagemedium. Thus, the data amount may be reduced. The database may beprotected by a password. Thus, the script cannot be viewed nor changeddue to encryption. The password may be created by the operating system.Thus, a simple way of protecting the settings data can be provided.

Starting the instrument may include booting the instrument. Booting theinstrument may include detecting whether the storage medium is receivedby the instrument. Thus, normal booting of the instrument can includelooking for the script. Booting the instrument may be disabled when thescript is executed. Thus, normal booting of the instrument from astorage medium can be disabled but the boot sequence of the instrumentcan look for the script and can allow the same to be executed.

The storage medium may be given an identification number which can belogged. Thus, logging all data extractions can be provided.

Restoring settings of the instrument may include inputting of a passwordby a user. Thus, restoring, or updating, of the settings can be onlycarried out if an operator, or user, is inclined to do so.

The instrument may comprise a display device. The input menu may beprovided on the display device. Thus, a user friendly handling of thescript can be provided. The input menu may be configured to allow a userto exit the input menu without inputting the saving and/or restoringcommand. The instrument can be booted in case of an exit of the inputmenu. Thus, execution of the script may be prevented by the user of theinstrument in order to allow booting of the instrument.

The storage medium may be an USB storage device such as, for example, anUSB stick. Thus, a common storage device may be used to store thescript. Accordingly, as USB connection devices are common to mostinstrument in the field of the disclosed method/system, the method maybe carried out with almost every instrument in the field of thedisclosed method/system.

Further, according to the disclosed method/system, a system comprisingan instrument for processing a sample or reagent is disclosed. Theinstrument can comprise a control unit and an operating system. Thesystem can further comprise a storage medium. The storage medium cancomprise a script. The script can comprise restoring data for restoringsettings of the instrument. The instrument can be configured to carryout each step of the method as described above.

The instrument may comprise a connection device configured to receivethe storage medium. Thus, the connection device can allow a user toinsert the storage medium into the instrument. The operating system maybe configured to start the instrument with the storage medium receivedby the instrument. The script may be encrypted and/or digitally signed.The operating system may be configured to verify an identity and/orintegrity of the script. The instrument may be configured to execute thescript in case the identity and/or integrity of the script correspondsto an identity and/or integrity of the instrument. The control unit maybe configured to provide an input menu for allowing a user to input asaving and/or restoring command. Further, the instrument may beconfigured to save settings of the instrument on the storage mediumand/or to restore settings of the instrument from the storage medium bythe restoring data corresponding to or dependent on the saving and/orrestoring command.

Thus, the system can provide flexibility and security as using a scriptinstead of a software based approach can provides platform and devicetype independence. This can mean it can be run on an arm, x86, power pcand the like without the need to distribute different versions. Further,as the script can be encrypted and/or digitally signed, security of thedata transmission can be provided. Particularly, the script may bepassword free and data transmission can still be secured as the scriptcan only be executed if the identity and/or integrity of the script isverified.

Furthermore, a backup can be created at any time, even after a failureof the instrument when the normal software doesn't boot, as long as theinstrument hardware is healthy.

The storage medium may not be bootable. A storage medium not beingbootable can remove the risk of using a malicious bootable medium toaccess the data. It can allow a simple identification of theauthenticity of the stick using signing.

The script may be encrypted by a signature. Thus, a simpleidentification of the authenticity of the storage medium may be providedusing signing.

The operating system may be configured to decrypt the script when theidentity and/or integrity of the script correspond to the identityand/or integrity of the instrument. Thus, the script cannot be viewednor changed due to encryption but only after decryption.

The operating system may be configured to copy the restoring data fromthe storage medium to the instrument for restoring settings of theinstrument from the storage medium. Thus, the system can allow a fulldata backup or update which can be particularly relevant for debuggingpurposes wherein an issue could be caused due to unknown data.

The operating system may be configured to decrypt the restoring datafrom the storage medium for restoring settings of the instrument fromthe storage medium. Thus, it can be ensured that the restoring data canonly be copied to the instrument if the identity and/or integrity of thescript correspond to the identity and/or integrity of the instrument asonly in this case the restoring data are decrypted. Thus, security ofthe restoring data can be increased.

The operating system may be configured to copy settings data on thestorage medium for saving settings of the instrument on the storagemedium. Thus, backup data may be generated and the settings may beduplicated. The operating system may be configured to encrypt settingsdata on the storage medium for saving settings of the instrument on thestorage medium. Thus, system can allow the settings to be securelystored.

The instrument may be configured to store the settings in a database.The operating system may be configured to copy the database on thestorage medium for saving the settings. Thus, a generation of fullbackup data can be possible. The operating system may be configured tocompress the database before being copied on the storage medium. Thus,the data amount may be reduced.

The instrument may be configured to protect the database by a password.Thus, the script cannot be viewed nor changed due to encryption. Theoperating system may be configured to create the password. Thus, asimple way of protecting the settings data can be provided.

The operating system may be configured to boot the instrument forstarting of the instrument. The operating system may be configured todetect whether the storage medium is received by the instrument duringbooting of the instrument. Thus, instrument can look for the scriptduring normal booting.

Booting the instrument may be disabled when the script is executed.Thus, normal booting of the instrument from a storage medium can bedisabled but the boot sequence of the instrument can look for the scriptand allow the same to be executed.

The storage medium may be given an identification number which can belogged. Thus, logging all data extractions can be provided.

The control unit may be configured to require inputting of a password bya user for restoring settings of the instrument. Thus, restoring orupdating of the settings can only be carried out if a user is inclinedto do so.

The storage medium may be a USB storage device such as, for example, anUSB stick. Thus, a common storage device may be used to store thescript. Accordingly, as USB connection devices are common to mostinstruments in the field of the disclosed method/system, the method maybe carried out with almost every instrument in the field of thedisclosed method/system.

The instrument may comprise a display device. The control unit can beconfigured to provide the input menu on the display device. Thus, a userfriendly handling of the script can be provided.

The input menu may be configured to allow a user to exit the input menuwithout inputting the saving and/or restoring command. The operatingsystem can be configured to boot the instrument in case of an exit ofthe input menu. Thus, execution of the script may be prevented by theuser of the instrument in order to allow booting of the instrument.

A computer script is also presents and can include computer-executableinstructions for performing the method according to the disclosedmethod/system in one or more of the embodiments enclosed herein when thescript is executed on a computer or computer network. Specifically, thecomputer script may be stored on a computer-readable data carrier. Thus,specifically, one, more than one or even all of the method steps asindicated above may be performed by using a computer, or a computernetwork, in particular by using a computer script.

A computer script product having script code is also presented toperform the method according to the disclosed method/system in one ormore of the embodiments enclosed herein when the script can be executedon a computer, or computer network. Specifically, the script code may bestored on a computer-readable data carrier.

Further, a data carrier having a data structure stored thereon ispresented which, after loading into a computer or computer network, suchas, for example, into a working memory or main memory of the computer,or computer network, may execute the method according to one or more ofthe embodiments disclosed herein.

A computer script product with script code stored on a machine-readablecarrier is presented; in order to perform the method according to one ormore of the embodiments disclosed herein, when the script can beexecuted on a computer, or computer network. As used herein, a computerscript product can refer to the script as a tradable product. Theproduct may generally exist in an arbitrary format, such as in a paperformat, or on a computer-readable data carrier. Specifically, thecomputer script product may be distributed over a data network.

Finally, a modulated data signal is presented which can containinstructions readable by a computer system, or computer network, forperforming the method according to one or more of the embodimentsdisclosed herein.

Referring to the computer-implemented aspects, one or more of the methodsteps or even all of the method steps of the method according to one ormore of the embodiments disclosed herein may be performed by using acomputer, or computer network. Thus, generally, any of the method stepsincluding provision and/or manipulation of data may be performed byusing a computer, or computer network. Generally, these method steps mayinclude any of the method steps, typically except for method stepsrequiring manual work, such as providing the samples and/or certainaspects of performing the actual measurements.

Specifically, the disclosed method/system further discloses:

a computer or computer network comprising at least one processor,wherein the processor is adapted to perform the method according to oneof the embodiments described in this description,

a computer loadable data structure that is adapted to perform the methodaccording to one of the embodiments described in this description whilethe data structure is being executed on a computer,

a computer script, wherein the computer script is adapted to perform themethod according to one of the embodiments described in this descriptionwhile the script is being executed on a computer,

a computer script comprising a script for performing the methodaccording to one of the embodiments described in this description whilethe computer script is being executed on a computer or on a computernetwork,

a computer script comprising a script according to the precedingembodiment, wherein the script is stored on a storage medium readable toa computer,

a storage medium, wherein a data structure is stored on the storagemedium and wherein the data structure is adapted to perform the methodaccording to one of the embodiments described in this description afterhaving been loaded into a main and/or working storage of a computer orof a computer network, and

a computer script product having script code, wherein the script codecan be stored or is stored on a storage medium, for performing themethod according to one of the embodiments described in thisdescription, if the script code is executed on a computer or on acomputer network.

Summarizing the findings of the disclosed method/system, the followingembodiments are disclosed:

A method for restoring settings of an instrument for processing a sampleor reagent is presented. The instrument can comprise a control unit andan operating system. The method can comprise providing a storage medium.The storage medium can comprise a script. The script can compriserestoring data for restoring settings of the instrument. The script canbe encrypted/digitally signed. The instrument can receive the storagemedium. The method can further comprise verifying an identity and/orintegrity of the script, executing the script upon starting theinstrument by the operating system with the storage medium received bythe instrument when the identity and/or integrity of the scriptcorresponds to an identity and/or integrity of the instrument, providingan input menu by the control unit for allowing a user to input arestoring command, and saving settings of the instrument on the storagemedium and/or restoring settings of the instrument from the storagemedium by the restoring data corresponding to the restoring command.

The storage medium may not be bootable.

The script can be encrypted by a signature.

The method can further comprise decrypting the script when the identityof the script corresponds to the identity of the instrument.

Restoring settings of the instrument from the storage medium can includecopying the restoring data from the storage medium to the instrument.

Restoring settings of the instrument from the storage medium can includedecrypting the restoring data from the storage medium.

Saving settings of the instrument on the storage medium can includecopying settings data on the storage medium.

Saving settings of the instrument on the storage medium can includeencrypting settings data on the storage medium.

The settings of the instrument can be stored in a database. Savingsetting can include copying the database on the storage medium. Thedatabase can be compressed before being copied on the storage medium.The database can be protected by a password. The password can be createdby the operating system.

Starting of the instrument can include booting the instrument. Bootingthe instrument can include detecting whether the storage medium isinserted into the instrument. Booting the instrument can be disabledwhen the script is executed.

The storage medium can be given an identification number which can belogged.

Restoring settings of the instrument can include inputting a password bya user.

The storage medium can be an USB storage device.

The instrument can comprise a display device. The input menu can beprovided on the display device. The input menu can be configured toallow a user to exit the input menu without inputting the restoringcommand. The instrument can be booted in case of an exit of the inputmenu.

A system comprising an instrument for processing a sample or reagent ispresented. The instrument can comprise a control unit, an operatingsystem, and a storage medium. The storage medium can comprise a script.The script can comprise restoring data for restoring settings of theinstrument. The instrument can be configured to carry out the abovemethod. The instrument can comprise a connection device configured toallow the storage medium to be inserted into the instrument. Theoperating system can be configured to start the instrument with thestorage medium inserted into the instrument and to execute the script.The control unit can be configured to provide an input menu for allowinga user to input a saving and/or restoring command. The instrument can beconfigured to save settings of the instrument on the storage mediumand/or to restore settings of the instrument from the storage medium bythe restoring data corresponding to the saving and/or restoring command.

The operating system can be configured to decrypt the script when theidentity of the script corresponds to the identity of the instrument.

The operating system can be configured to copy the restoring data fromthe storage medium to the instrument for restoring settings of theinstrument from the storage medium.

The operating system can be configured to decrypt the restoring datafrom the storage medium for restoring settings of the instrument fromthe storage medium.

The operating system can be configured to copy settings data on thestorage medium for saving settings of the instrument on the storagemedium.

The operating system can be configured to encrypt settings data on thestorage medium for saving settings of the instrument on the storagemedium.

The instrument can be configured to store the settings in a database.The operating system can be configured to copy the database on thestorage medium for saving the settings. The operating system can beconfigured to compress the database before being copied on the storagemedium. The instrument can be configured to protect the database by apassword. The operating system can be configured to create the password.

The operating system can be configured to boot the instrument forstarting of the instrument. The operating system can be configureddetect whether the storage medium is inserted into the instrument duringbooting of the instrument. Booting the instrument can be disabled whenthe script is executed.

The control unit can be configured to require inputting of a password bya user for restoring settings of the instrument.

Referring initially to FIG. 1, FIG. 1 shows a perspective view of asystem 100 comprising an instrument 102 for processing a sample 104 orreagent. The instrument 102 can comprise a control unit 106 and anoperating system 108. The control unit 106 may be a commerciallyavailable PC or the like on which the operating system 108 can run. Thesystem 100 can further comprise a non-bootable storage medium 110. Thestorage medium 110 may be a USB stick or the like. The storage medium110 may be given an identification number which can be logged. Thestorage medium 110 can comprise a script 112. The script 112 cancomprise restoring data for restoring settings of the instrument 102.The script 112 can be encrypted. Alternatively, or in addition, thescript 112 may be digitally signed. In one embodiment, the script 112can be encrypted by a signature.

The instrument 102 can further comprise a connection device 114configured to receive the storage medium 110. The connection device 114can allow a user to insert the storage medium 110 into the instrument102. For example, the connection device 114 may be an USB slot. Theinstrument 102 can further comprise a display device 116. The displaydevice 116 may be a monitor. The display device 116 may comprise agraphical user interface such as a touch screen for allowing a user tocommunicate with the instrument 102 by inputting commands andinstructions, respectively.

The instrument 102 may also be called a laboratory instrument. Forexample, the instrument 102 can be an analyzer, or analyticalinstrument. As such, the analyzer can be configured to obtain ameasurement value form the sample 104. The analyzer can be operable todetermine a parameter value of the sample 104, or a component thereof.For example, the analyzer can be configured to be used as point of caretesting.

The term “point of care testing” as used herein can encompass analysisof one or more patient sample(s) at or near the site of patient care,i.e., a healthcare setting where medical, or medically related services,can be provided, such as emergency departments, intensive care units;primary care setting; medical centers, and the like. Point of caretesting can often be accomplished through the use of transportable,portable, and handheld instruments, but small bench analyzers or fixedequipment can also be used when a handheld device is not available. Thegoal can be to collect the patient sample and obtain the analytical datain a very short period of time at or near the location of the patient.For example, the patient may be a human person, the sample may be humanblood and the analyzer may be configured to detect blood glucose valueas measuring data.

Thus, the instrument 102 can be configured to obtain measuring data fromthe sample 104. The so obtained measuring data can be stored in thecontrol unit 106. The instrument 102 can be configured to carry out theanalyzing process according to the settings thereof. Needless to say,the settings of the instrument 102 can comprise further or other datafor operating the instrument 102. The settings may be stored in adatabase of the instrument 102. The database may be protected by apassword created by the operating system 108.

FIG. 2 shows a flow chart of a method for saving and/or restoringsettings of the instrument 102. Basically, each of the method stepsdescribed below may be carried out by the instrument 102. In step S1,the instrument 102 can be started by the operating system 108. In stepS2, the operating system 102 can begin to boot and to launch a storagemedium detection script. In other words, when the instrument 102 isbooted, it can begin to execute a storage medium script for detecting areceipt of the storage medium 110. In step S3, the operating system 108can detect whether the storage medium 110 is inserted into or receivedby the instrument 102 and the connection device 114, respectively.

If the storage medium 110 is not received by the instrument 102, themethod can proceed to step S4. The instrument 102 can be regularly, ornormally, booted. In the case, the storage medium 110 is detected, themethod can proceed to step S5. The storage medium 110 can be received bythe instrument 102 and the connection device 114, respectively. In stepS6, the operating system 108 can verify an identity and/or integrity ofthe script 112. In other words, the operating system 108 can checkwhether a correctly named and encrypted script file is found on thestorage medium 110. If the identity and/or integrity of the script 112does not correspond to an identity and/or integrity of the instrument102, i.e., the script 112 is not the correct one, the method can returnsto step S4. i.e., the instrument 102 can be booted normally. If theidentity and/or integrity of the script 112 correspond to an identityand/or integrity of the instrument 102, i.e. the script 112 is thecorrect one, the method can proceed to step S7, wherein the script 112can be decrypted and executed by the operating system 108. When thescript 112 is executed, booting of the instrument 102 can be disabled.The instrument 102 cannot be booted from the storage medium 110 as it isa non-bootable storage medium 110.

Subsequently, the method can proceed to step S8, wherein the controlunit 106 can provide an input menu on the display device 116. The usermay input commands within the input menu by the graphical user interfaceof the display device 116. The input menu can allow a user to make aselection. More particularly, the user may select between three optionsinputted in step S9. As a first option, the user may exit the input menuwithout inputting any other command other than an exit command. In thiscase, the method can proceed to step S4. As a second option, the inputmenu can allows the user to input a saving command. As a third option,the input menu can allow the user to input a restoring command. If theuser inputs a saving command in step S9, the method can proceed to stepS10, wherein the settings data can be copied from the instrument 102 tothe storage medium 110 by the operating system 108 for saving settingsof the instrument 102. More particularly, the operating system 108 cancopy the database, in which the settings can be stored, on the storagemedium 110. The operating system 108 may compress the database beforebeing copied on the storage medium 110. The settings data may beencrypted. For example, the instrument 102 may protect the database by apassword created by the operating system 108. Subsequently, the methodcan return to step S9.

If the user inputs a restoring command in step S9, the method canproceed to step S11, wherein the restoring data can be copied from thestorage medium 110 to the instrument 102. More particularly, the controlunit 106 can require inputting of a password by a user for restoringsettings of the instrument 102 in order to decrypt the restoring datafor restoring settings of the instrument 102 from the storage medium110. Then the settings of the instrument 102 can be restored. Therestoring process may also include an update process. Subsequently, themethod can return to step S9.

It is noted that terms like “preferably,” “commonly,” and “typically”are not utilized herein to limit the scope of the claimed embodiments orto imply that certain features are critical, essential, or evenimportant to the structure or function of the claimed embodiments.Rather, these terms are merely intended to highlight alternative oradditional features that may or may not be utilized in a particularembodiment of the present disclosure.

Having described the present disclosure in detail and by reference tospecific embodiments thereof, it will be apparent that modifications andvariations are possible without departing from the scope of thedisclosure defined in the appended claims. More specifically, althoughsome aspects of the present disclosure are identified herein aspreferred or particularly advantageous, it is contemplated that thepresent disclosure is not necessarily limited to these preferred aspectsof the disclosure.

I claim:
 1. A method for restoring settings of an instrument forprocessing a sample or reagent, wherein the instrument comprises acontrol unit and an operating system, the method comprises: providing astorage medium, wherein the storage medium comprises a script andrestoring data for restoring settings of the instrument, wherein thescript is encrypted/digitally signed and wherein the instrument receivesthe storage medium; verifying an identity and/or integrity of thescript; executing the script upon starting the instrument by theoperating system with the storage medium received by the instrument whenthe identity and/or integrity of the script corresponds to an identityof the instrument; providing an input menu by the control unit forallowing a user to input a saving and/or restoring command; and savingsettings of the instrument on the storage medium and/or restoringsettings of the instrument from the storage medium by the restoring datacorresponding to the saving and/or restoring command.
 2. The methodaccording to claim 1, wherein the storage medium is not bootable.
 3. Themethod according to claim 1, further comprising, decrypting the scriptwhen the identity and/or integrity of the script corresponds to theidentity and/or integrity of the instrument.
 4. The method according toclaim 1, wherein restoring settings of the instrument from the storagemedium includes copying and decrypting the restoring data from thestorage medium to the instrument.
 5. The method according to claim 1,wherein the saving of settings of the instrument on the storage mediumincludes copying and encrypting settings data on the storage medium. 6.The method according to claim 1, wherein the settings of the instrumentare stored in a database.
 7. The method according to claim 6, whereinthe saving of settings includes copying the database on the storagemedium, and wherein the database is compressed before being copied onthe storage medium.
 8. The method according to claim 7, wherein thedatabase is compressed before being copied on the storage medium.
 9. Themethod according to claim 1, wherein the starting of the instrumentincludes booting of the instrument.
 10. The method according to claim 9,wherein the booting of the instrument includes detecting whether thestorage medium is inserted into the instrument.
 11. The method accordingto claim 9, wherein the booting of the instrument is disabled when thescript is executed.
 12. A system, the system comprising: an instrumentfor processing a sample or reagent and a storage medium, wherein theinstrument comprises: a control unit, and an operating system, whereinthe storage medium comprises a script, wherein the script comprisesrestoring data for restoring settings of the instrument, wherein thescript is encrypted and/or digitally signed, wherein the instrument isconfigured to carry out the method according to claim
 1. 13. The systemaccording to claim 12, wherein the instrument further comprises, aconnection device configured to allow the storage medium to be receivedby the instrument, wherein the operating system is configured to: startthe instrument with the storage medium received by the instrument,verify an identity and/or integrity of the script, execute the scriptwhen the identity and/or integrity of the script corresponds to anidentity and/or integrity of the instrument; wherein the control unit isconfigured to provide an input menu for allowing a user to input asaving and/or restoring command; and wherein the instrument isconfigured to save settings of the instrument on the storage mediumand/or to restore settings of the instrument from the storage medium bythe restoring data corresponding to the saving and/or restoring command.14. The system according to claim 13, wherein the instrument comprises adisplay device, wherein control unit is configured to provide the inputmenu on the display device.
 15. The system according to claim 12,wherein the storage medium is not bootable.
 16. The system according toclaim 12, wherein the operating system is configured to decrypt thescript when the identity of the script corresponds to the identity ofthe instrument.
 17. The system according to claim 12, wherein theoperating system is configured to copy and decrypt the restoring datafrom the storage medium to the instrument for restoring settings of theinstrument from the storage medium.
 18. The system according to claim12, wherein the operating system is configured to copy and encryptsettings data on the storage medium for saving settings of theinstrument on the storage medium.